WTO “Paragraph 6” system for affordable access to medicines: Relief or regulatory ritualism?

• DOI: http://doi.org/10.1111/jwip.12083
• Author: Muhammad Z. Abbas,Shamreeza Riaz
• Published date: 01 March 2018
• Date: 01 March 2018

DOI: 10.1111/jwip.12083

ORIGINAL ARTICLE

WTO “Paragraph 6”system for affordable access

to medicines: Relief or regulatory ritualism?

Muhammad Z. Abbas BA, LLB, LLM, PhD

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Shamreeza Riaz BA, LLB, LLM, PhD

Queensland University of Technology,

Brisbane, Australia

Correspondence

Shamreeza Riaz, Queensland University of

Technology, George Street, GPO Box 2434,

Brisbane QLD 4000 CRICOS No. 00213J,

Australia.

Email: shamreeza.riaz@hdr.qut.edu.au

Regulatory Ritualism means acceptance of regulatory goals

while losing focus in achieving them. In other words, it means

ignoring of goals or objectives of a process or mechanism and

focusing too much on regulations, rules, and formalities.

Advanced countries and developing countries have been in a

continuous negotiation over access to drugs ever since

coming into effect of TRIPS Agreement. The Doha Declara-

tion was a rare negotiation win for third world countries. This

paper endeavors to apply the notion of Regulatory Ritualism

to Paragraph 6 of the Doha Declaration 2001 and to

subsequent WTO General Council's Waiver Decision 2003

which aimed at giving effect to Paragraph 6 flexibility. The

first part of the paper discusses the historical background of

the Doha Declaration and 2003 Decision. The second part of

this paper analyses Paragraph 6 of the Doha Declaration and

subsequent Waiver Decision in the light of the notion of

Regulatory Ritualism and Rule Complexity, with a special focus

on Apotex-Rwanda case study, the case of India and the case

of Australia. The final part of this paper sums up the

discussion on the issue and provides suggestions.

KEYWORDS

Apotex-Rwanda, access to drugs, compulsory licensing, Doha

Declaration, Paragraph 6, patent monopoly, public health,

regulatory ritualism, rule complexity, TRIPS flexibilities

© 2017 The Authors. The Journal of World Intellectual Property © 2017 John Wiley & Sons Ltd

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wileyonlinelibrary.com/journal/jwip J World Intellect Prop. 2018;21:32–51.

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INTRODUCTION

The Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement required patent protection for

inventions in all fields of technology including pharmaceuticals (WTO, 1994). An obvious and direct consequence of

monopoly on drugs is an increase in prices of needed medicines; patent protection on medicines, therefore, emerged

as a common issue for third world countries where purchasing power is too low to afford patented medicines (Rozek,

2000). The access to drugs problem was foreseen and TRIPS included public health safeguards like non-voluntary

licensing of drug patents but this flexibility was of little significance for least developed countries

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and developing

countries with no drug manufacturing capacity because of the “domestic use”condition attached to it (WTO, 1994).

This very issue was highlighted by human rights activists, NGOs, and public health advocates in the wake of the

outbreak of HIV/AIDS in Africa in the very beginning of the Twenty-first century. The Doha Declaration 2001 (TRIPS,

2001), and subsequent WTO General Council's Waiver Decision 2003 (WTO, 2003a, 2003b, 2003c) aimed at

reforming the existing system in order to resolve the issue of access to drugs for poorer countries.

It has been observed that the issue of access to drugs has remained a hot issue even after breakthrough pro-

access developments like Doha Declaration (WTO, 2001) and 2003 Waiver Decision. The adoption of a resolution on

“Access to medicines in the context of the right of everyone to the enjoyment of the highest attainable standard of

physical and mental health”presented by 13 countries (Saez, 2016)

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in the 32nd session of the Human Rights Council

(13 June 2016–1 July 2016) is a recent development in this regard (Kulkarni, 2016). The resolution notes that actual or

potential conflicts exist between the implementation of the TRIPS Agreement and access to affordable medicines

(Mitra-Jha, 2016); the resolution urges member states to make full use of TRIPS flexibilities for affordable access to

medicines (Human Rights Council, 2016) and specifically recalls the Doha Ministerial Declaration on the TRIPS

Agreement and Public Health in this context (Kulkarni, 2016). The resolution fully recognizes the implications of

pharmaceutical patent monopoly for policy coherence in developing countries.

The United Nations Secretary-General's High-Level Panel on Access to Medicines Report released on 14

September 2016, is another recent development. The Report found that the Paragraph 6 system has failed to provide

a workable solution for countries lacking drug manufacturing capacity of their own. The Report recommended that

“WTO Members should revise the paragraph 6 decision in order to find a solution that enables a swift and expedient

export of pharmaceutical products produced under compulsory license”(UN, 2016). On one hand, World Health

Organization aims that “by 2030, the deadline for the Sustainable Development Goals, all countries must be able to

provide full coverage for quality health services to their entire populations”(Kieny, 2016) while on the other hand

access to drugs remains an “illusive goal”for millions of people (Mitra-Jha, 2016).

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Bilateral and regional free-trade agreements, which set TRIPS-Plus intellectual property standards, have arguably

constrained the use of legitimate TRIPS flexibilities reaffirmed in the Doha Declaration (Abbas & Riaz, 2013). The

Trans-Pacific Partnership (TPP)—an ambitious free trade agreement that the United States has negotiated with 11

other countries (New Zealand, Australia, Canada, Japan, Singapore, Brunei Darussalam, Chile, Malaysia, Mexico, Peru,

and Vietnam)—is the most recent example of such trade deals requiring enhanced rights and remedies for

multinational drug companies. Article 18.6.1(b) recognizes the right of member states to utilize the Waiver flexibility

but it neither makes any commitment for effective implementation of this public health solution nor puts any

obligation on member states to take necessary steps to use this flexibility for the sake of improving access to essential

medicines in the poorer countries. This provision stipulates that:

In recognition of the commitment to access to medicines that are supplied in accordance with the Decision

of the General Council of August 30, 2003 on the Implementation of Paragraph Six of the Doha Declaration

on the TRIPS Agreement and Public Health (WT/L/540) and the WTO General Council Chairman's

Statement Accompanying the Decision (JOB(03)/177, WT/GC/M/82), as well as the Decision of the WTO

General Council of December 6, 2005 on the Amendment of the TRIPS Agreement, (WT/L/641) and the

WTO General Council Chairperson's Statement Accompanying the Decision (JOB(05)319 and Corr. 1,WT/

ABBAS AND RIAZ

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